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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Perfusion, Kidney
510(k) Number K083453
Device Name COSTORSOL
Applicant
Preservation Solutions, Inc.
4250 Grove St.
Denver,  CO  80211
Applicant Contact NEIL BURRIS
Correspondent
Preservation Solutions, Inc.
4250 Grove St.
Denver,  CO  80211
Correspondent Contact NEIL BURRIS
Regulation Number876.5880
Classification Product Code
KDN  
Date Received11/21/2008
Decision Date 01/21/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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